Regulatory Information
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2net Regulatory Information
Intended Use Statement
The 2net Hub is used in the 2net Platform to capture and transmit
medical device data. The 2net Hub is intended to receive, convert
(from one format to another), store and transfer data from a
connected medical device and to act as a medical device data
system (MDDS). The 2net Hub transfers the data wirelessly, via
either WiFi or cellular network, to the 2net Platform. The 2net Hub
performs these functions without controlling or altering the function
or parameters of any connected medical devices.
The transfer of data from the 2net Hub is subject to time delays
and potential data loss due to conditions in which the 2net Hub
and the 2net Platform are operating, including: network or power
disruptions, connectivity interruptions, medical and mobile device
limitations and user error, time zone offsets, and other conditions
outside the control of the 2net Hub or the 2net Platform.
The 2net Hub is not to be relied upon for transmitting data
necessary to inform immediate medical decisions, for transmitting
continuously (24/7 or similar), for the time-sensitive monitoring
of a patient, or for connecting to emergency response systems.
Wireless Devices
The Hub contains radio transmitters and uses non-ionizing
radio frequencies (“RF”). The Hub operates within the exposure
limits for an uncontrolled environment as set by the U.S. Federal
Communications Commission (“FCC”) and Innovation and Science
and Economic Development Canada (“ISED”). The 2net Hub should
be installed and operated with a minimum distance of 8 inches (20
cm) between the radiator (Hub) and any person.
Scientific research on wireless devices and RF energy has been
conducted worldwide for many years, and continues. In the United
States, the Food and Drug Administration (“FDA”) and the FCC
set standards and regulations pertaining to wireless devices. The
